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510(k) K250215

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand by Cochlear — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2025
Date Received
January 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

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Other clearances for product code LXB

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  • K213733 — Ponto 5 SuperPower (December 16, 2021)
  • K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Sma (September 29, 2021)
  • K211640 — Ponto 5 Mini (August 10, 2021)
  • K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear (February 23, 2021)
  • K190540 — Ponto 4 (May 2, 2019)
  • K172460 — ADHEAR System (April 27, 2018)
  • K171088 — Cochlear Baha SoundArc (June 7, 2017)
  • K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (September 29, 2016)
  • K153391 — Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (June 16, 2016)